Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial

Coronary Artery Disease Clinical Trial

— ISAR-CLOSURE  

Official title:

Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389375
• Other study ID #: GE IDE No. PCD00111
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2011
• Last updated: June 8, 2016
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?

Description:

Vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. This effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest.

However, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature.

This trial compares, in a randomised design two novel vascular closure devices (FemoSeal & ExoSeal) versus manual compression after coronary angiography. This study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4524
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient between 18 and 85 years of age

• Patients undergoing femoral access coronary angiography

• Access only with 6 F sheath

• Patient must be competent for providing informed written consent

Exclusion Criteria:

• Peripheral arterial occlusive disease

• Prior peripheral artery surgery

• Percutaneous coronary intervention

• Femoral access device closure in last 30 days

• Scheduled Coronary Angiography/Intervention within 90 days

• Critical limb ischemic

• Uncontrolled hypertension >220/110 mmHg

• Coagulopathy (bleeding disorder)

• Local infection

• Common femoral artery lumen diameter < 5 mm

• Allergy to absorbable suture

• Autoimmune Disease

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• FemoSeal®
Closure device for femoral artery access closure
• ExoSeal®
Closure device for femoral artery access closure

Other:
• Manual compression
Conventional manual compression

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Klinikum rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schulz-Schüpke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Böttiger C, Groha P, Bradaric C, Schmidt R, Bott-Flügel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A; Instrumental Sealing of Arterial Puncture Site—CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of arterial access related complications	Composite of arterial access related complications, defined as the composite of: Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm; Pseudoaneurysm; AV-Fistula; Major bleeding; Critical limb ischemia; Local infection; Surgical repair; Revascularisation	30 days	Yes
Secondary	Time to hemostasis, from sheath removal to complete hemostasis		30 days	Yes
Secondary	Device deployment failure		30 days	No
Secondary	Need for repeated manual compression after end of closure procedure		30 days	Yes
Secondary	Cost-benefit Analysis		30 days	No